Tapered SwissPlus® SPB10Recalls & reported problems
ZimVie US Corp LLC · Class 2 · Implant
Quick summary
This ZimVie Tapered SwissPlus dental implant is a root-form implant placed in the jawbone to hold a dental restoration. Its 102 FDA reports mostly describe implants failing from peri-implantitis, an infection of the gum and bone around the implant, and some describe bone loss, pain and swelling. Of the 102 reports, 88 describe injuries, and there are no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 100
- Deaths reported
- 0
- Injuries reported
- 86
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 100 adverse event reports that list this exact device (DI 00889024017177), received between Jan 15, 2020 and Jul 27, 2026 — classified as 86 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Separation Failure” (9 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem79
- Separation Failure9
- Fracture5
- Detachment of Device or Device Component2
- Separation Problem2
- Component Missing1
- Device Markings/Labelling Problem1
- Premature Separation1
Patient problems
- Unspecified Infection62
- Osteolysis57
- Pain24
- No Clinical Signs, Symptoms or Conditions22
- Inflammation17
- Swelling/ Edema8
- No Information6
- No Code Available3
Recent adverse event reports
The 25 most recent of 100 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem
It was reported that an implant was removed due to a peri-implantitis. Tooth site 46. Patient suffered from inflammation and pain.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 50017317 ↗InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT A TOOTH SITE #42 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25449566 ↗InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #11 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT SUFFERED FROM PAIN TWO WEEKS AFTER PLACEMENT, WITH RECURRENCE AFTER A COURSE OF ANTIBIOTICS.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 25284325 ↗InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #33 LOST INTEGRATION DUE TO PERI-IMPLANTITIS. THE PATIENT WILL RETURN TO COMPLETE THE PROCEDURE.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25218510 ↗InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #36 WAS REMOVED DUE TO PERI-IMPLANTITIS. DOCTOR PERFORMED CURETTAGE. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 25184261 ↗InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANTS WERE REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24699731 ↗InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 33 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, INFLAMMATION AND EDEMA.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24520269 ↗InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #33 AND #43 WERE REMOVED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED BY PLACING OTHER IMPLANTS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24497445 ↗InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 23840499 ↗InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis; Pain; Swelling/ Edema
MAUDE report 23830322 ↗MalfunctionDec 4, 2025Separation Failure; Separation Failure
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Inflammation; Pain
MAUDE report 23714435 ↗InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #35 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23480602 ↗InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #15 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT HAD PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 23383848 ↗InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. TOOTH SITE #46.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22685248 ↗InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Erosion; Inflammation; Sinus Perforation
MAUDE report 22667052 ↗MalfunctionJul 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE DOCTOR REPORTED THAT THE IMPLANT WAS LOOSE INSIDE THE CONTAINER, POORLY SCREWED IN, AND THEREFORE FELL AND BECAME CONTAMINATED. PROCEDURE WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22369424 ↗InjuryJun 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION #13 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. BONE TYPE: UNKNOWN.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22208207 ↗InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 22199819 ↗InjuryJun 2, 2025Fracture; Fracture
IT WAS REPORTED A FRACTURE IN THE MIDDLE OF THE IMPLANT AT TOOTH SITE 26. THE PROCESS WAS COMPLETED WITH ANOTHER IMPLANT. NO IMPACT ON THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22124029 ↗InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 14 WAS REMOVED DUE TO PERI-IMPLANTITIS WITH ABSCESS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21705381 ↗InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DUE TO PERI IMPLANTITIS THE IMPLANT LOST INTEGRATION AND WAS REMOVED. TOOTH LOCATION 43.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21570726 ↗MalfunctionMar 3, 2025Separation Failure; Separation Failure
DOCTOR REPORTED THAT BOTH MOUNTS CANNOT BE DISENGAGED FROM IMPLANTS. ANOTHER IMPLANT WAS PLACED IN THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21502244 ↗MalfunctionMar 3, 2025Separation Failure; Separation Failure
DOCTOR REPORTED THAT BOTH MOUNTS CANNOT BE DISENGAGED FROM IMPLANTS. ANOTHER IMPLANT WAS PLACED IN THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21502192 ↗InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 21256730 ↗InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT ON TOOTH LOCATION 46 WAS REMOVED DUE TO PERI-IMPLANTITIS. PAIN, ABCESS AND INFLAMMATION REPORTED AS A CONSEQUENCE OF THE EVENT. IMPLANT REMOVED AND CURETTAGE PERFORMED. REPLACEMENT SCHEDULED.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 21250433 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.